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Design and rationale of the COMPLETE trial: A randomized, comparative effectiveness study of complete versus culprit-only percutaneous coronary intervention to treat multivessel coronary artery disease in patients presenting with ST-segment elevation myocardial infarction - 05/08/19

Doi : 10.1016/j.ahj.2019.06.006 
Shamir R. Mehta, MD, MSc a, b, c, , David A. Wood, MD d, Brandi Meeks, MEng, MSc a, Robert F. Storey, MD e, Roxana Mehran, MD f, Kevin R. Bainey, MD, MSc g, Helen Nguyen, BSc a, Shrikant I. Bangdiwala, PhD a, b, John A. Cairns, MD d

on Behalf of the COMPLETE Trial Steering Committee and Investigators

a Population Health Research Institute, Hamilton, Ontario, Canada 
b McMaster University, Hamilton, Ontario, Canada 
c Hamilton Health Sciences, Hamilton, Ontario, Canada 
d University of British Columbia, Vancouver, British Columbia, Canada 
e Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom 
f The Zena A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY 
g Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Alberta, Canada 

Reprint requests: Shamir R. Mehta MD, MSc, Population Health Research Institute, Hamilton General Hospital, 237 Barton St E., Hamilton, Ontario, Canada L8L 2X2.Population Health Research Institute, Hamilton General HospitalHamiltonOntarioCanada

Introduction

A significant proportion of patients with ST-segment elevation myocardial infarction (STEMI) have multivessel coronary artery disease (CAD). Following successful culprit lesion percutaneous coronary intervention (PCI) for STEMI, the question of whether to routinely revascularize non-culprit lesions or manage them conservatively with optimal medical therapy (OMT) alone is a common dilemma facing clinicians.

Methods

COMPLETE is a prospective, randomized, international, multicenter, parallel group, open-label trial with blinded evaluation of outcomes. Following successful PCI (contemporary drug eluting stents recommended) of the culprit lesion for STEMI, a total of 4041 patients from 140 centers in 31 countries were randomized to receive either complete revascularization, consisting of staged PCI of all suitable non-culprit lesions plus optimal medical therapy (OMT), or to culprit lesion-only PCI, consisting of OMT alone. OMT comprises evidence-based therapy for STEMI, including and dual antiplatelet therapy with ticagrelor, HTN and lipid management. All coronary angiograms in the trial are being evaluated in a central angiographic core lab to assess quality and completeness of revascularization. The co-primary outcomes are (1): the composite of CV death or new non-fatal MI and (2 the composite of CV death, new non-fatal MI or ischemia-driven revascularization at a median follow-up of 3 years.

Conclusions

The COMPLETE trial is an international multicenter randomized trial that will help determine whether complete revascularization involving staged PCI of non-culprit lesions improves outcomes in patients with STEMI and multivessel CAD. (clinicaltrials.gov NCT01740479).

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 RCT# NCT01740479


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Vol 215

P. 157-166 - Settembre 2019 Ritorno al numero
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